2025-523802-34-00招募中2 期
An Adaptive Dose Escalation and Expansion Basket Trial to Explore the Safety, Pharmacology, and Clinical Activity of TGD001 in Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP) and Other Thrombotic Microangiopathies
TargED Biopharmaceuticals B.V.4 个研究点 分布在 4 个国家目标入组 40 人开始时间: 2026年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Treatment emergent adverse events
研究概览
简要总结
To assess the safety and tolerability of TGD001 in participants with suspicion or clinical diagnosis of an acute iTTP episode
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult: age ≥18 at the time of signing the informed consent form (ICF)
- •Willing and able to provide informed consent and sign the ICF
- •Male or female of childbearing potential must refrain from sexual intercourse or must use a contraceptive method that is highly effective (with a failure rate of <1% per year) during the trial and for at least 90 days after the last dose of trial drug
- •Symptomatic acute TMA episode
- •Patient accessible to follow-up
排除标准
- •Diagnosis other than TMA, which could account for the findings of thrombocytopenia and hemolytic anemia (e.g., disseminated intravascular coagulation [DIC], Evans syndrome)
- •Pre-existing severe medical, neurological, or psychiatric disease that would significantly confound the endpoint evaluations (Investigator judgment)
- •Known hypersensitivity to any of the trial treatments or their excipients or to drugs of similar chemical classes
- •Participant participating in a trial involving an investigational drug or device within the last 30 days that would impact this trial
- •Participants who cannot comply with trial protocol requirements and procedures
- •Severe active infection indicated by sepsis (requirement for pressors with or without positive blood cultures)
- •Pregnant or breastfeeding
- •History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
- •Active internal bleeding
- •Indication of symptomatic intracranial hemorrhage (sICH)
- •Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
- •Disseminated malignancy or other co-morbid illness limiting life expectancy <3 months independent of the TMA disorder
- •Recent major surgery (Investigator judgment)
研究组 & 干预措施
null
Test
干预措施: null (Drug)
结局指标
主要结局
Treatment emergent adverse events
Treatment emergent adverse events
次要结局
- Time to clinical response
- Change in platelet count from baseline
- Time to recovery of platelets to ≥150×10E9/L
- Change of organ damage markers from baseline
- Time to recovery of LDH to ≤2 × ULN
- Assessment or improvement (improvement of ≥1 grade in CTCAE v5.0 scale) of disease-related signs and symptoms within 90 days post intervention (by number of unique participants and by total number of AEs)
- Number of days in the intensive care unit and the number of days hospitalized
- All-cause and disease-specific mortality within 90 days post-intervention
- Plasma concentrations of TGD001, PK parameters such as Cmax, Tmax, AUC, t1/2
- Development of ADA
研究者
Marielle Hesselink
Scientific
TargED Biopharmaceuticals B.V.
研究点 (4)
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